510(k) · Cleared
ClearedBD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · JTN Susceptibility Test Discs, Antimicrobial
Cleared on Jun 7, 2023 as substantially equivalent to K192326 (Hardy Diagnostics, 2019) after a 90-day review. Its family tree reaches back 1 generation to 2019.
- Decided
- Jun 7, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- JTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K192326 (2019). No later device cites it as a predicate yet.
- Root · 1 generation backK192326 HardyDisk AST Lefamulin 20µg (LMU20)Hardy Diagnostics · 2019
- This deviceK230651 BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)Becton, Dickinson and Company · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K192326 | HardyDisk AST Lefamulin 20µg (LMU20) | Hardy Diagnostics | 2019 | — |
| 0 (this device) | K230651 | BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20) | Becton, Dickinson and Company | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JTN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JTN device
- #1 K221826 BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)score 4.6 · 1 generation · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K192326 | HardyDisk AST Lefamulin 20µg (LMU20)Summary page 6…d. V Substantial Equivalence Information: A Predicate Device Name: HardyDisk AST Lefamulin 20µg (LMU20) B Predicate 510(k) Number: K192326 C Comparison with Predicate: Device & Device: Predicate:… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All JTN devicesJTN Susceptibility Test Discs, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · JTN
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JTN
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JTN
31in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JTN
7in 2025
MAUDE reports naming product code JTN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 2 |
| 2008 | 4 | 44 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 15 | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 3 | 0 |
| 2013 | 0 | — | 5 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 3 | 56 | 1 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 3 | 33 | 0 | 0 |
| 2018 | 3 | 27 | 0 | 0 |
| 2019 | 3 | 23 | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 5 |
| 2022 | 2 | — | 0 | 5 |
| 2023 | 4 | 67 | 0 | 4 |
| 2024 | 2 | — | 31 | 5 |
| 2025 | 7 | 87 | 0 | 7 |
| 2026 | 4 | 56 | 1 | — |
What is it indicated for?
BD BBL Sensi-Disc Antimicrobial Susceptibility Test (AST) Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing.
BD BBL Sensi-Disc Lefamulin Disc 20 μg (LMU-20) can be used to determine susceptibility to Lefamulin against the following bacteria, as described in the FDA-approved package insert for this antimicrobial agent.
Active in vitro and in Clinical Infections Against:
Gram-positive Bacteria
Streptococcus pneumoniae
Staphylococcus aureus (methicillin-susceptible isolates)
Gram-negative Bacteria
Haemophilus influenzae
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230651 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230651: BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230651
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026